Demo logical data model
1.0.0 - STU1 International flag

Demo logical data model, published by My Organization. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/wgroup6/11615 and changes regularly. See the Directory of published versions

Logical Model: IDMP11615Investigational - Detailed Descriptions

Active as of 2023-10-31

Definitions for the InvestigationalMedicinalProduct logical model.

Guidance on how to interpret the contents of this table can be found here

0. InvestigationalMedicinalProduct
Definition

ISO 11615 Investigational Medicinal Product

Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. InvestigationalMedicinalProduct.IMPID
Definition

The identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2)

ShortThe identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2)
Control1..1
TypeIdentifier
4. InvestigationalMedicinalProduct.CombinedPharmaceuticalDoseForm
Definition

The combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3)

ShortThe combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3)
Control0..1
TypeCodeableConcept
6. InvestigationalMedicinalProduct.SponsorProductCode
Definition

The product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4)

ShortThe product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
8. InvestigationalMedicinalProduct.RegulatorProductCode
Definition

The product code (identifier) for the Investigational Medicinal Product as designated by the Medicines Regulatory Agency can be specified in text. Either this code or the sponsor product code (see 11.3. 2.2.4 ) shall be specified. (11.3.2.2.5)

ShortThe product code (identifier) for the Investigational Medicinal Product as designated by the Medicines Regulatory Agency can be specified in text. Either this code or the sponsor product code (see 11.3. 2.2.4 ) shall be specified. (11.3.2.2.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
10. InvestigationalMedicinalProduct.PaediatricUseIndicator
Definition

If the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6)

ShortIf the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6)
Control0..1
TypeCodeableConcept
12. InvestigationalMedicinalProduct.ClinicalTrialStatus
Definition

The status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7)

ShortThe status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7)
Control0..1
TypeCodeableConcept
14. InvestigationalMedicinalProduct.OrphanDesignationStatus
Definition

See 9.2.2.2.7 . (11.3.2.2.8)

ShortSee 9.2.2.2.7 . (11.3.2.2.8)
Control0..1
TypeCodeableConcept
16. InvestigationalMedicinalProduct.AttachedDocument
Definition

11.3.2.6

Short11.3.2.6
Control1..*
TypeBackboneElement
18. InvestigationalMedicinalProduct.AttachedDocument.Identifier
Definition

The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)

ShortThe reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)
Control1..1
TypeIdentifier
20. InvestigationalMedicinalProduct.AttachedDocument.EffectiveDate
Definition

The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)

ShortThe date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
22. InvestigationalMedicinalProduct.AttachedDocument.Type
Definition

The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)

ShortThe type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)
Control1..1
TypeCodeableConcept
24. InvestigationalMedicinalProduct.AttachedDocument.Content
Definition

The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)

ShortThe actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)
Control1..1
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
26. InvestigationalMedicinalProduct.AttachedDocument.Language
Definition

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)

ShortThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)
Control0..1
TypeCodeableConcept
28. InvestigationalMedicinalProduct.AttachedDocument.MediaType
Definition

This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)

ShortThis attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)
Control0..1
TypeCodeableConcept
30. InvestigationalMedicinalProduct.AttachedDocument.VersionNumber
Definition

This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)

ShortThis is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
32. InvestigationalMedicinalProduct.AttachedDocument.VersionSetIdentifier
Definition

This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)

ShortThis is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)
Control0..1
TypeIdentifier
34. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation
Definition

11.4.2.2

Short11.4.2.2
Control1..*
TypeBackboneElement
36. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.RegistrationNumber
Definition

The registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2)

ShortThe registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2)
Control1..1
TypeIdentifier
38. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.InvestigationCode
Definition

The code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3)

ShortThe code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
40. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Country
Definition

The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4)

ShortThe jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4)
Control1..*
TypeCodeableConcept
42. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.ProtocolNumber
Definition

The number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5)

ShortThe number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5)
Control1..1
TypeIdentifier
44. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.AuthorisationDate
Definition

The date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6)

ShortThe date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
46. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.AnticipatedEndDate
Definition

The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7)

ShortThe date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
48. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation
Definition

11.4.2.3

Short11.4.2.3
Control0..*
TypeBackboneElement
50. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalClinicalTrialRegistrationNumber
Definition

The registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2)

ShortThe registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2)
Control1..1
TypeIdentifier
52. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalInvestigationCode
Definition

The “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3)

ShortThe “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
54. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.Jurisdiction
Definition

The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4)

ShortThe jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4)
Control1..*
TypeCodeableConcept
56. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalAuthorisationDate
Definition

The date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5)

ShortThe date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
58. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalAnticipatedEndDate
Definition

The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6)

ShortThe date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
60. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control1..1
TypeBackboneElement
62. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
64. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
66. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
68. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
70. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
72. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
74. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
76. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
78. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
80. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
82. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
84. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
86. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
88. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
90. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
92. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
94. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation
Definition

11.4.2.4

Short11.4.2.4
Control1..1
TypeBackboneElement
96. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
98. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
100. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
102. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
104. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
106. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
108. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
110. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
112. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
114. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
116. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
118. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
120. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
122. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
124. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
126. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
128. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME
Definition

9.3.2.4

Short9.3.2.4
Control0..1
TypeBackboneElement
130. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.SMEFlag
Definition

This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)

ShortThis is a flag to indicate if the organisation is an SME. (9.3.2.4.1)
Control1..1
TypeElement(BL)
132. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.Size
Definition

The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)

ShortThe size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)
Control0..1
TypeCodeableConcept
134. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.SMENumber
Definition

This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)

ShortThis is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)
Control0..1
TypeIdentifier
136. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.StatusDate
Definition

This is the date when the SME status was granted. (9.3.2.4.4)

ShortThis is the date when the SME status was granted. (9.3.2.4.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
138. InvestigationalMedicinalProduct.Contraindication
Definition

9.9.2.3

Short9.9.2.3
Control0..*
TypeBackboneElement
140. InvestigationalMedicinalProduct.Contraindication.ContraindicationsText
Definition

The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)

ShortThe text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
142. InvestigationalMedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)

ShortThe underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)
Control0..1
TypeCodeableConcept
144. InvestigationalMedicinalProduct.Contraindication.DiseaseStatus
Definition

The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)

ShortThe status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)
Control0..1
TypeCodeableConcept
146. InvestigationalMedicinalProduct.Contraindication.Comorbidity
Definition

The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)

ShortThe comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)
Control0..*
TypeCodeableConcept
148. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement
150. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeCodeableConcept
152. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeCodeableConcept
154. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement
156. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
158. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
160. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
162. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
164. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
166. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept
168. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication
Definition

9.9.2.2

Short9.9.2.2
Control0..*
TypeBackboneElement
170. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IndicationText
Definition

The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)

ShortThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
172. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)

ShortThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
Control0..1
TypeCodeableConcept
174. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus
Definition

The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)

ShortThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
Control0..1
TypeCodeableConcept
176. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity
Definition

If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)

ShortIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
Control0..*
TypeCodeableConcept
178. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect
Definition

The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)

ShortThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
Control0..1
TypeCodeableConcept
180. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration
Definition

If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)

ShortIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
Control0..1
TypeQuantity
182. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement
184. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeCodeableConcept
186. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeCodeableConcept
188. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control1..*
TypeBackboneElement
190. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
192. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
194. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
196. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
198. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
200. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept
202. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement
204. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
206. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeCodeableConcept
208. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeCodeableConcept
210. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeCodeableConcept
212. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement
214. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
216. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
218. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
220. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
222. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
224. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept
226. InvestigationalMedicinalProduct.Header
Definition

11.3.2.5

Short11.3.2.5
Control1..1
TypeBackboneElement
228. InvestigationalMedicinalProduct.Header.Identifier
Definition

This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)

ShortThis attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)
Control1..1
TypeIdentifier
230. InvestigationalMedicinalProduct.Header.EffectiveDate
Definition

The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)

ShortThe date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
232. InvestigationalMedicinalProduct.Header.Language
Definition

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)

ShortThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)
Control0..1
TypeCodeableConcept
234. InvestigationalMedicinalProduct.Header.VersionNumber
Definition

This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)

ShortThis is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
236. InvestigationalMedicinalProduct.Header.VersionSetIdentifier
Definition

This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)

ShortThis is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)
Control0..1
TypeIdentifier
238. InvestigationalMedicinalProduct.Interactions
Definition

9.9.2.7

Short9.9.2.7
Control0..*
TypeBackboneElement
240. InvestigationalMedicinalProduct.Interactions.InteractionsText
Definition

The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)

ShortThe text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
242. InvestigationalMedicinalProduct.Interactions.Interactant
Definition

This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)

ShortThis element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)
Control0..*
TypeCodeableConcept
244. InvestigationalMedicinalProduct.Interactions.InteractionsType
Definition

The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)

ShortThe type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)
Control0..1
TypeCodeableConcept
246. InvestigationalMedicinalProduct.Interactions.InteractionsEffect
Definition

The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)

ShortThe effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)
Control0..1
TypeCodeableConcept
248. InvestigationalMedicinalProduct.Interactions.InteractionsIncidence
Definition

The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)

ShortThe incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)
Control0..1
TypeCodeableConcept
250. InvestigationalMedicinalProduct.Interactions.ManagementActions
Definition

The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)

ShortThe actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)
Control0..1
TypeCodeableConcept
252. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName
Definition

11.3.2.8

Short11.3.2.8
Control1..1
TypeBackboneElement
254. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FullName
Definition

The full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1)

ShortThe full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
256. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Code
Definition

The Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2)

ShortThe Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
258. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.InventedNamePart
Definition

The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)

ShortThe invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
260. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.ScientificNamePart
Definition

The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)

ShortThe scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
262. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.StrengthPart
Definition

The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)

ShortThe strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
264. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.PharmaceuticalDoseFormPart
Definition

The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)

ShortThe pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
266. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FormulationPart
Definition

The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)

ShortThe formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
268. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.IntendedUsePart
Definition

The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)

ShortThe intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
270. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.TargetPopulationPart
Definition

The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)

ShortThe target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
272. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.ContainerOrPackPart
Definition

The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)

ShortThe container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
274. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.DevicePart
Definition

The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)

ShortThe device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
276. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.TrademarkOrCompanyNamePart
Definition

The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)

ShortThe trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
278. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Time-PeriodPart
Definition

The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)

ShortThe time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
280. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FlavourPart
Definition

The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)

ShortThe flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
282. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.DelimiterPart
Definition

A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)

ShortA delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
284. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language
Definition

9.2.2.9

Short9.2.2.9
Control1..*
TypeBackboneElement
286. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Country
Definition

The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)

ShortThe country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)
Control1..1
TypeCodeableConcept
288. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Jurisdiction
Definition

The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)

ShortThe jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)
Control0..1
TypeCodeableConcept
290. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Language
Definition

The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)

ShortThe language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)
Control1..1
TypeCodeableConcept
292. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct
Definition

11.2.7

Short11.2.7
Control0..*
TypeBackboneElement
294. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.IPCID
Definition

This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)

ShortThis is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)
Control1..1
TypeIdentifier
296. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageDescription
Definition

A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)

ShortA textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
298. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier
Definition

9.6.2.8

Short9.6.2.8
Control0..*
TypeBackboneElement
300. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.BAID1
Definition

The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)

ShortThe BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)
Control1..1
TypeIdentifier
302. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.BAID2
Definition

The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)

ShortThe BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)
Control0..1
TypeIdentifier
304. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.ExpirationDate
Definition

This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)

ShortThis is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
306. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
308. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
310. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
312. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
314. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
316. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
318. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
320. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
322. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
324. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
326. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
328. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
330. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
332. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
334. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
336. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
338. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
340. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
342. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
344. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
346. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
348. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
350. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
352. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
354. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
356. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
358. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
360. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
362. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
364. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
366. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
368. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
370. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
372. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
374. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
376. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
378. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
380. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
382. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
384. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container
Definition

9.6.2.3

Short9.6.2.3
Control1..*
TypeBackboneElement
386. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerType
Definition

The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)

ShortThe package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)
Control1..1
TypeCodeableConcept
388. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerQuantity
Definition

The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)

ShortThe quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)
Control1..1
TypeQuantity
390. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Material
Definition

The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)

ShortThe material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)
Control1..*
TypeCodeableConcept
392. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.AlternateMaterial
Definition

The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)

ShortThe alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)
Control0..*
TypeCodeableConcept
394. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier
Definition

9.6.2.4

Short9.6.2.4
Control0..*
TypeBackboneElement
396. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.CodeSystem
Definition

The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)

ShortThe data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)
Control1..1
TypeCodeableConcept
398. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.Value
Definition

The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)

ShortThe individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)
Control1..1
TypeCodeableConcept
400. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device
Definition

9.6.2.12

Short9.6.2.12
Control0..*
TypeBackboneElement
402. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceType
Definition

The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)

ShortThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
Control1..1
TypeCodeableConcept
404. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceTradeName
Definition

This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)

ShortThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
406. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceQuantity
Definition

The quantity of the device present in the pack shall be specified. (9.6.2.12.4)

ShortThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
Control1..1
TypeQuantity
408. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceListingNumber
Definition

This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)

ShortThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
410. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceIdentifier
Definition

A unique device identifier needs to be specified. (9.6.2.12.6)

ShortA unique device identifier needs to be specified. (9.6.2.12.6)
Control0..1
TypeIdentifier
412. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ModelNumber
Definition

This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)

ShortThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
414. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.SterilityIndicator
Definition

Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)

ShortWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
Control0..1
TypeCodeableConcept
416. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.SterilisationRequirementIndicator
Definition

Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)

ShortWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
Control0..1
TypeCodeableConcept
418. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceUsage
Definition

The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)

ShortThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
Control0..1
TypeCodeableConcept
420. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier
Definition

11.12

Short11.12
Control0..*
TypeBackboneElement
422. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.BatchNumber
Definition

Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)

ShortWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
424. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.ExpirationDate
Definition

Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)

ShortWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
426. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial
Definition

9.6.2.13

Short9.6.2.13
Control0..*
TypeBackboneElement
428. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Substance
Definition

The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)

ShortThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
Control1..1
TypeCodeableConcept
430. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Alternate
Definition

This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)

ShortThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
Control0..1
TypeElement(BL)
432. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.AllergenicIndicator
Definition

This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)

ShortThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
Control0..1
TypeElement(BL)
434. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature
Definition

11.11

Short11.11
Control0..*
TypeBackboneElement
436. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.CodeSystem
Definition

The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)

ShortThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
Control1..1
TypeCodeableConcept
438. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.Value
Definition

The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)

ShortThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
Control1..1
TypeCodeableConcept
440. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..1
TypeBackboneElement
442. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
444. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
446. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
448. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
450. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
452. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
454. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
456. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
458. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
460. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
462. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
464. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
466. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
468. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
470. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
472. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
474. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
476. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
478. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
480. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
482. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
484. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
486. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
488. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
490. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
492. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
494. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
496. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
498. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
500. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
502. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
504. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
506. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
508. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
510. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
512. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
514. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
516. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
518. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement
520. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeCodeableConcept
522. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeCodeableConcept
524. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics
Definition

11.13

Short11.13
Control0..1
TypeBackboneElement
526. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeQuantity
528. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeQuantity
530. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeQuantity
532. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeQuantity
534. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeQuantity
536. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeQuantity
538. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
540. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
542. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
544. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
546. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeCodeableConcept
548. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement
550. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeCodeableConcept
552. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeQuantity
554. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeCodeableConcept
556. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem
Definition

9.6.2.20

Short9.6.2.20
Control0..*
TypeBackboneElement
558. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedDoseForm
Definition

This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)

ShortThis describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)
Control1..1
TypeCodeableConcept
560. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.UnitOfPresentation
Definition

This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)

ShortThis specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)
Control0..1
TypeCodeableConcept
562. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedItemQuantity
Definition

The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)

ShortThe quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)
Control1..1
TypeQuantity
564. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient
Definition

11.2.9

Short11.2.9
Control1..*
TypeBackboneElement
566. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.IngredientRole
Definition

The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)

ShortThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
Control1..1
TypeCodeableConcept
568. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.AllergenicIndicator
Definition

This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)

ShortThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
Control0..1
TypeElement(BL)
570. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
572. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
574. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
576. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
578. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
580. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
582. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
584. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
586. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
588. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
590. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
592. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
594. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
596. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
598. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
600. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
602. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
604. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
606. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
608. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
610. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
612. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
614. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
616. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
618. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
620. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
622. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
624. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
626. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
628. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
630. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
632. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
634. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
636. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
638. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
640. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
642. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
644. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
646. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
648. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance
Definition

9.7.2.4

Short9.7.2.4
Control0..*
TypeBackboneElement
650. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance
Definition

When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)

ShortWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
Control1..1
TypeCodeableConcept
652. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup
Definition

The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)

ShortThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
Control1..1
TypeCodeableConcept
654. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator
Definition

The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)

ShortThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
Control0..1
TypeCodeableConcept
656. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control0..*
TypeBackboneElement
658. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeRatio
660. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeRatio
662. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
664. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeCodeableConcept
666. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement
668. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeCodeableConcept
670. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeCodeableConcept
672. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeRatio
674. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
676. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeCodeableConcept
678. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance
Definition

9.7.2.3

Short9.7.2.3
Control0..1
TypeBackboneElement
680. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Substance
Definition

A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)

ShortA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
Control1..1
TypeCodeableConcept
682. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control1..*
TypeBackboneElement
684. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeRatio
686. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeRatio
688. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
690. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeCodeableConcept
692. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement
694. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeCodeableConcept
696. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeCodeableConcept
698. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeRatio
700. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
702. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeCodeableConcept
704. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
706. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
708. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
710. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
712. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
714. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
716. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
718. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
720. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
722. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
724. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
726. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
728. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
730. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
732. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
734. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
736. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
738. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
740. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
742. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
744. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
746. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
748. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
750. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
752. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
754. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
756. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
758. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
760. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
762. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
764. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
766. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
768. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
770. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
772. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
774. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
776. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
778. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
780. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
782. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement
784. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeCodeableConcept
786. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeCodeableConcept
788. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics
Definition

11.13

Short11.13
Control0..1
TypeBackboneElement
790. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeQuantity
792. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeQuantity
794. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeQuantity
796. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeQuantity
798. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeQuantity
800. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeQuantity
802. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
804. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
806. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
808. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
810. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeCodeableConcept
812. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
814. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
816. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
818. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
820. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
822. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
824. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
826. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
828. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
830. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
832. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
834. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
836. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
838. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
840. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
842. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
844. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
846. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
848. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
850. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
852. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
854. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
856. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
858. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
860. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
862. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
864. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
866. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
868. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
870. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
872. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
874. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
876. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
878. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
880. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
882. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
884. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
886. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
888. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
890. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement
892. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeCodeableConcept
894. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeCodeableConcept
896. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component
Definition

9.6.2.9

Short9.6.2.9
Control0..*
TypeBackboneElement
898. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentType
Definition

The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)

ShortThe type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)
Control1..1
TypeCodeableConcept
900. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentMaterial
Definition

The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)

ShortThe material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)
Control0..*
TypeCodeableConcept
902. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentAlternateMaterial
Definition

Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)

ShortAlternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)
Control0..*
TypeCodeableConcept
904. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
906. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
908. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
910. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
912. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
914. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
916. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
918. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
920. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
922. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
924. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
926. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
928. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
930. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
932. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
934. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
936. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
938. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
940. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
942. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
944. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
946. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
948. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
950. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
952. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
954. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
956. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
958. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
960. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
962. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
964. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
966. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
968. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
970. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
972. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
974. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
976. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
978. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
980. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
982. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics
Definition

11.13

Short11.13
Control0..1
TypeBackboneElement
984. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeQuantity
986. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeQuantity
988. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeQuantity
990. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeQuantity
992. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeQuantity
994. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeQuantity
996. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
998. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1000. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1002. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1004. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeCodeableConcept
1006. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics
Definition

11.13

Short11.13
Control0..1
TypeBackboneElement
1008. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeQuantity
1010. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeQuantity
1012. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeQuantity
1014. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeQuantity
1016. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeQuantity
1018. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeQuantity
1020. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1022. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1024. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1026. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1028. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeCodeableConcept
1030. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement
1032. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeCodeableConcept
1034. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeQuantity
1036. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeCodeableConcept
1038. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
1040. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1042. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1044. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1046. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1048. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1050. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
1052. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1054. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1056. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1058. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1060. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
1062. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1064. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1066. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1068. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1070. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1072. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
1074. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
1076. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
1078. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1080. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
1082. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
1084. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1086. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1088. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1090. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1092. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1094. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
1096. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1098. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1100. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1102. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1104. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
1106. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1108. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1110. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1112. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1114. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1116. InvestigationalMedicinalProduct.OrphanDesignation
Definition

9.2.2.3

Short9.2.2.3
Control0..*
TypeBackboneElement
1118. InvestigationalMedicinalProduct.OrphanDesignation.OrphanIndicationType
Definition

This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)

ShortThis attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)
Control1..1
TypeCodeableConcept
1120. InvestigationalMedicinalProduct.OrphanDesignation.OrphanProcedureNumber
Definition

This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)

ShortThis attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)
Control0..1
TypeIdentifier
1122. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus
Definition

This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)

ShortThis attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)
Control1..1
TypeCodeableConcept
1124. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate
Definition

This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)

ShortThis attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1126. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationNumber
Definition

This field is to indicate the orphan designation decision number. (9.2.2.3.6)

ShortThis field is to indicate the orphan designation decision number. (9.2.2.3.6)
Control0..1
TypeIdentifier
1128. InvestigationalMedicinalProduct.PharmaceuticalProduct
Definition

11.7.2

Short11.7.2
Control1..*
TypeBackboneElement
1130. InvestigationalMedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm
Definition

This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)

ShortThis shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)
Control1..1
TypeCodeableConcept
1132. InvestigationalMedicinalProduct.PharmaceuticalProduct.UnitOfPresentation
Definition

The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)

ShortThe unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)
Control0..1
TypeCodeableConcept
1134. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device
Definition

9.6.2.12

Short9.6.2.12
Control0..*
TypeBackboneElement
1136. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceType
Definition

The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)

ShortThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
Control1..1
TypeCodeableConcept
1138. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName
Definition

This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)

ShortThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1140. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity
Definition

The quantity of the device present in the pack shall be specified. (9.6.2.12.4)

ShortThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
Control1..1
TypeQuantity
1142. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber
Definition

This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)

ShortThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1144. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier
Definition

A unique device identifier needs to be specified. (9.6.2.12.6)

ShortA unique device identifier needs to be specified. (9.6.2.12.6)
Control0..1
TypeIdentifier
1146. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ModelNumber
Definition

This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)

ShortThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1148. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator
Definition

Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)

ShortWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
Control0..1
TypeCodeableConcept
1150. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator
Definition

Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)

ShortWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
Control0..1
TypeCodeableConcept
1152. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage
Definition

The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)

ShortThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
Control0..1
TypeCodeableConcept
1154. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier
Definition

11.12

Short11.12
Control0..*
TypeBackboneElement
1156. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber
Definition

Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)

ShortWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1158. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate
Definition

Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)

ShortWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1160. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial
Definition

9.6.2.13

Short9.6.2.13
Control0..*
TypeBackboneElement
1162. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance
Definition

The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)

ShortThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
Control1..1
TypeCodeableConcept
1164. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate
Definition

This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)

ShortThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
Control0..1
TypeElement(BL)
1166. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator
Definition

This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)

ShortThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
Control0..1
TypeElement(BL)
1168. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature
Definition

11.11

Short11.11
Control0..*
TypeBackboneElement
1170. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem
Definition

The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)

ShortThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
Control1..1
TypeCodeableConcept
1172. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value
Definition

The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)

ShortThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
Control1..1
TypeCodeableConcept
1174. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..1
TypeBackboneElement
1176. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1178. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1180. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1182. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1184. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1186. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
1188. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1190. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1192. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1194. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1196. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
1198. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1200. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1202. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1204. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1206. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1208. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
1210. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
1212. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
1214. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1216. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
1218. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
1220. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1222. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1224. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1226. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1228. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1230. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
1232. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1234. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1236. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1238. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1240. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
1242. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1244. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1246. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1248. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1250. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1252. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement
1254. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeCodeableConcept
1256. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeCodeableConcept
1258. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics
Definition

11.13

Short11.13
Control0..1
TypeBackboneElement
1260. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeQuantity
1262. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeQuantity
1264. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeQuantity
1266. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeQuantity
1268. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeQuantity
1270. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeQuantity
1272. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1274. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1276. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1278. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1280. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeCodeableConcept
1282. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement
1284. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeCodeableConcept
1286. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeQuantity
1288. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeCodeableConcept
1290. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration
Definition

11.7.3

Short11.7.3
Control1..*
TypeBackboneElement
1292. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.RouteOfAdministration
Definition

(11.7.3.0)

Short (11.7.3.0)
Control1..1
TypeCodeableConcept
1294. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.FirstDoseInHumans
Definition

The first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2)

ShortThe first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2)
Control0..1
TypeQuantity
1296. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumSingleDose
Definition

The maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3)

ShortThe maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3)
Control0..1
TypeQuantity
1298. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumDosePerDay
Definition

The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4)

ShortThe maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4)
Control0..1
TypeQuantity
1300. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumDosePerTreatmentPeriod
Definition

The maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5)

ShortThe maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5)
Control0..1
TypeRatio
1302. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumTreatmentPeriod
Definition

The maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6)

ShortThe maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6)
Control0..1
TypeQuantity
1304. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient
Definition

11.2.9

Short11.2.9
Control1..*
TypeBackboneElement
1306. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole
Definition

The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)

ShortThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
Control1..1
TypeCodeableConcept
1308. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator
Definition

This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)

ShortThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
Control0..1
TypeElement(BL)
1310. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
1312. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1314. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1316. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1318. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1320. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1322. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
1324. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1326. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1328. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1330. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1332. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
1334. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1336. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1338. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1340. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1342. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1344. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
1346. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
1348. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
1350. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1352. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
1354. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
1356. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1358. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1360. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1362. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1364. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1366. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
1368. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1370. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1372. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1374. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1376. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
1378. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1380. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1382. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1384. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1386. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1388. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance
Definition

9.7.2.4

Short9.7.2.4
Control0..*
TypeBackboneElement
1390. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance
Definition

When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)

ShortWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
Control1..1
TypeCodeableConcept
1392. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup
Definition

The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)

ShortThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
Control1..1
TypeCodeableConcept
1394. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator
Definition

The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)

ShortThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
Control0..1
TypeCodeableConcept
1396. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control0..*
TypeBackboneElement
1398. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeRatio
1400. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeRatio
1402. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1404. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeCodeableConcept
1406. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement
1408. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeCodeableConcept
1410. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeCodeableConcept
1412. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeRatio
1414. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1416. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeCodeableConcept
1418. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance
Definition

9.7.2.3

Short9.7.2.3
Control0..1
TypeBackboneElement
1420. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance
Definition

A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)

ShortA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
Control1..1
TypeCodeableConcept
1422. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control1..*
TypeBackboneElement
1424. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeRatio
1426. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeRatio
1428. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1430. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeCodeableConcept
1432. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement
1434. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeCodeableConcept
1436. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeCodeableConcept
1438. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeRatio
1440. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1442. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeCodeableConcept
1444. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics
Definition

9.8.2.4

Short9.8.2.4
Control0..*
TypeBackboneElement
1446. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem
Definition

The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)

ShortThe code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)
Control1..1
TypeCodeableConcept
1448. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value
Definition

The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)

ShortThe individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)
Control1..1
TypeCodeableConcept
1450. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status
Definition

The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)

ShortThe status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)
Control0..1
TypeCodeableConcept
1452. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet
Definition

9.8.2.6

Short9.8.2.6
Control1..*
TypeBackboneElement
1454. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets
Definition

This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)

ShortThis class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)
Control1..1
TypeIdentifier
1456. InvestigationalMedicinalProduct.ProductClassification
Definition

11.3.2.7

Short11.3.2.7
Control0..*
TypeBackboneElement
1458. InvestigationalMedicinalProduct.ProductClassification.CodeSystem
Definition

The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)

ShortThe Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)
Control1..1
TypeCodeableConcept
1460. InvestigationalMedicinalProduct.ProductClassification.Value
Definition

The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)

ShortThe individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)
Control1..1
TypeCodeableConcept
1462. InvestigationalMedicinalProduct.ProductCross-Reference
Definition

11.3.2.4

Short11.3.2.4
Control0..*
TypeBackboneElement
1464. InvestigationalMedicinalProduct.ProductCross-Reference.I-MPIDCross-Reference
Definition

This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)

ShortThis is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)
Control1..1
TypeIdentifier
1466. InvestigationalMedicinalProduct.ProductCross-Reference.ReferencedProductType
Definition

This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)

ShortThis attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)
Control0..1
TypeCodeableConcept
1468. InvestigationalMedicinalProduct.TherapeuticIndication
Definition

9.9.2.2

Short9.9.2.2
Control1..*
TypeBackboneElement
1470. InvestigationalMedicinalProduct.TherapeuticIndication.IndicationText
Definition

The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)

ShortThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1472. InvestigationalMedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)

ShortThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
Control0..1
TypeCodeableConcept
1474. InvestigationalMedicinalProduct.TherapeuticIndication.DiseaseStatus
Definition

The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)

ShortThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
Control0..1
TypeCodeableConcept
1476. InvestigationalMedicinalProduct.TherapeuticIndication.Comorbidity
Definition

If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)

ShortIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
Control0..*
TypeCodeableConcept
1478. InvestigationalMedicinalProduct.TherapeuticIndication.IntendedEffect
Definition

The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)

ShortThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
Control0..1
TypeCodeableConcept
1480. InvestigationalMedicinalProduct.TherapeuticIndication.Timing-Duration
Definition

If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)

ShortIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
Control0..1
TypeQuantity
1482. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement
1484. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeCodeableConcept
1486. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeCodeableConcept
1488. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control1..*
TypeBackboneElement
1490. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
1492. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
1494. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
1496. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
1498. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
1500. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept
1502. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement
1504. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1506. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeCodeableConcept
1508. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeCodeableConcept
1510. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeCodeableConcept
1512. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement
1514. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
1516. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
1518. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
1520. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
1522. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
1524. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept
1526. InvestigationalMedicinalProduct.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement
1528. InvestigationalMedicinalProduct.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1530. InvestigationalMedicinalProduct.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeCodeableConcept
1532. InvestigationalMedicinalProduct.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeCodeableConcept
1534. InvestigationalMedicinalProduct.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeCodeableConcept
1536. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement
1538. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
1540. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
1542. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
1544. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
1546. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
1548. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept

Guidance on how to interpret the contents of this table can be found here

0. InvestigationalMedicinalProduct
Definition

ISO 11615 Investigational Medicinal Product

Control0..*
Is Modifierfalse
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. InvestigationalMedicinalProduct.IMPID
Definition

The identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2)

ShortThe identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2)
Control1..1
TypeIdentifier
4. InvestigationalMedicinalProduct.CombinedPharmaceuticalDoseForm
Definition

The combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3)

ShortThe combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3)
Control0..1
TypeCodeableConcept
6. InvestigationalMedicinalProduct.SponsorProductCode
Definition

The product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4)

ShortThe product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
8. InvestigationalMedicinalProduct.RegulatorProductCode
Definition

The product code (identifier) for the Investigational Medicinal Product as designated by the Medicines Regulatory Agency can be specified in text. Either this code or the sponsor product code (see 11.3. 2.2.4 ) shall be specified. (11.3.2.2.5)

ShortThe product code (identifier) for the Investigational Medicinal Product as designated by the Medicines Regulatory Agency can be specified in text. Either this code or the sponsor product code (see 11.3. 2.2.4 ) shall be specified. (11.3.2.2.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
10. InvestigationalMedicinalProduct.PaediatricUseIndicator
Definition

If the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6)

ShortIf the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6)
Control0..1
TypeCodeableConcept
12. InvestigationalMedicinalProduct.ClinicalTrialStatus
Definition

The status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7)

ShortThe status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7)
Control0..1
TypeCodeableConcept
14. InvestigationalMedicinalProduct.OrphanDesignationStatus
Definition

See 9.2.2.2.7 . (11.3.2.2.8)

ShortSee 9.2.2.2.7 . (11.3.2.2.8)
Control0..1
TypeCodeableConcept
16. InvestigationalMedicinalProduct.AttachedDocument
Definition

11.3.2.6

Short11.3.2.6
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. InvestigationalMedicinalProduct.AttachedDocument.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
20. InvestigationalMedicinalProduct.AttachedDocument.Identifier
Definition

The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)

ShortThe reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)
Control1..1
TypeIdentifier
22. InvestigationalMedicinalProduct.AttachedDocument.EffectiveDate
Definition

The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)

ShortThe date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
24. InvestigationalMedicinalProduct.AttachedDocument.Type
Definition

The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)

ShortThe type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)
Control1..1
TypeCodeableConcept
26. InvestigationalMedicinalProduct.AttachedDocument.Content
Definition

The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)

ShortThe actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)
Control1..1
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
28. InvestigationalMedicinalProduct.AttachedDocument.Language
Definition

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)

ShortThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)
Control0..1
TypeCodeableConcept
30. InvestigationalMedicinalProduct.AttachedDocument.MediaType
Definition

This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)

ShortThis attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)
Control0..1
TypeCodeableConcept
32. InvestigationalMedicinalProduct.AttachedDocument.VersionNumber
Definition

This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)

ShortThis is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
34. InvestigationalMedicinalProduct.AttachedDocument.VersionSetIdentifier
Definition

This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)

ShortThis is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)
Control0..1
TypeIdentifier
36. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation
Definition

11.4.2.2

Short11.4.2.2
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
40. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.RegistrationNumber
Definition

The registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2)

ShortThe registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2)
Control1..1
TypeIdentifier
42. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.InvestigationCode
Definition

The code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3)

ShortThe code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
44. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Country
Definition

The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4)

ShortThe jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4)
Control1..*
TypeCodeableConcept
46. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.ProtocolNumber
Definition

The number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5)

ShortThe number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5)
Control1..1
TypeIdentifier
48. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.AuthorisationDate
Definition

The date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6)

ShortThe date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
50. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.AnticipatedEndDate
Definition

The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7)

ShortThe date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
52. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation
Definition

11.4.2.3

Short11.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
56. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalClinicalTrialRegistrationNumber
Definition

The registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2)

ShortThe registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2)
Control1..1
TypeIdentifier
58. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalInvestigationCode
Definition

The “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3)

ShortThe “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
60. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.Jurisdiction
Definition

The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4)

ShortThe jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4)
Control1..*
TypeCodeableConcept
62. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalAuthorisationDate
Definition

The date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5)

ShortThe date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
64. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalAnticipatedEndDate
Definition

The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6)

ShortThe date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
66. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control1..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
70. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
72. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
74. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
76. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
78. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
80. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
84. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
86. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
88. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
90. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
92. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
94. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
96. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
98. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
100. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
102. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
104. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
106. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation
Definition

11.4.2.4

Short11.4.2.4
Control1..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
108. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
110. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
112. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
114. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
116. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
118. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
120. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
122. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
124. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
126. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
128. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
130. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
132. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
134. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
136. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
138. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
140. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
142. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
144. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
146. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME
Definition

9.3.2.4

Short9.3.2.4
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
148. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
150. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.SMEFlag
Definition

This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)

ShortThis is a flag to indicate if the organisation is an SME. (9.3.2.4.1)
Control1..1
TypeElement(BL)
152. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.Size
Definition

The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)

ShortThe size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)
Control0..1
TypeCodeableConcept
154. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.SMENumber
Definition

This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)

ShortThis is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)
Control0..1
TypeIdentifier
156. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.StatusDate
Definition

This is the date when the SME status was granted. (9.3.2.4.4)

ShortThis is the date when the SME status was granted. (9.3.2.4.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
158. InvestigationalMedicinalProduct.Contraindication
Definition

9.9.2.3

Short9.9.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
160. InvestigationalMedicinalProduct.Contraindication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
162. InvestigationalMedicinalProduct.Contraindication.ContraindicationsText
Definition

The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)

ShortThe text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
164. InvestigationalMedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)

ShortThe underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)
Control0..1
TypeCodeableConcept
166. InvestigationalMedicinalProduct.Contraindication.DiseaseStatus
Definition

The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)

ShortThe status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)
Control0..1
TypeCodeableConcept
168. InvestigationalMedicinalProduct.Contraindication.Comorbidity
Definition

The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)

ShortThe comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)
Control0..*
TypeCodeableConcept
170. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
172. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
174. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeCodeableConcept
176. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeCodeableConcept
178. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
180. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
182. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
184. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
186. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
188. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
190. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
192. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept
194. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication
Definition

9.9.2.2

Short9.9.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
196. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
198. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IndicationText
Definition

The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)

ShortThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
200. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)

ShortThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
Control0..1
TypeCodeableConcept
202. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus
Definition

The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)

ShortThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
Control0..1
TypeCodeableConcept
204. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity
Definition

If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)

ShortIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
Control0..*
TypeCodeableConcept
206. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect
Definition

The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)

ShortThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
Control0..1
TypeCodeableConcept
208. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration
Definition

If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)

ShortIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
Control0..1
TypeQuantity
210. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
212. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
214. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeCodeableConcept
216. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeCodeableConcept
218. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
220. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
222. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
224. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
226. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
228. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
230. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
232. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept
234. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
236. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
238. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
240. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeCodeableConcept
242. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeCodeableConcept
244. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeCodeableConcept
246. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
248. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
250. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
252. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
254. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
256. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
258. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
260. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept
262. InvestigationalMedicinalProduct.Header
Definition

11.3.2.5

Short11.3.2.5
Control1..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
264. InvestigationalMedicinalProduct.Header.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
266. InvestigationalMedicinalProduct.Header.Identifier
Definition

This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)

ShortThis attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)
Control1..1
TypeIdentifier
268. InvestigationalMedicinalProduct.Header.EffectiveDate
Definition

The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)

ShortThe date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
270. InvestigationalMedicinalProduct.Header.Language
Definition

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)

ShortThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)
Control0..1
TypeCodeableConcept
272. InvestigationalMedicinalProduct.Header.VersionNumber
Definition

This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)

ShortThis is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
274. InvestigationalMedicinalProduct.Header.VersionSetIdentifier
Definition

This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)

ShortThis is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)
Control0..1
TypeIdentifier
276. InvestigationalMedicinalProduct.Interactions
Definition

9.9.2.7

Short9.9.2.7
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
278. InvestigationalMedicinalProduct.Interactions.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
280. InvestigationalMedicinalProduct.Interactions.InteractionsText
Definition

The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)

ShortThe text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
282. InvestigationalMedicinalProduct.Interactions.Interactant
Definition

This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)

ShortThis element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)
Control0..*
TypeCodeableConcept
284. InvestigationalMedicinalProduct.Interactions.InteractionsType
Definition

The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)

ShortThe type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)
Control0..1
TypeCodeableConcept
286. InvestigationalMedicinalProduct.Interactions.InteractionsEffect
Definition

The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)

ShortThe effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)
Control0..1
TypeCodeableConcept
288. InvestigationalMedicinalProduct.Interactions.InteractionsIncidence
Definition

The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)

ShortThe incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)
Control0..1
TypeCodeableConcept
290. InvestigationalMedicinalProduct.Interactions.ManagementActions
Definition

The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)

ShortThe actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)
Control0..1
TypeCodeableConcept
292. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName
Definition

11.3.2.8

Short11.3.2.8
Control1..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
294. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
296. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FullName
Definition

The full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1)

ShortThe full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
298. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Code
Definition

The Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2)

ShortThe Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
300. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.InventedNamePart
Definition

The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)

ShortThe invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
302. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.ScientificNamePart
Definition

The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)

ShortThe scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
304. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.StrengthPart
Definition

The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)

ShortThe strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
306. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.PharmaceuticalDoseFormPart
Definition

The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)

ShortThe pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
308. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FormulationPart
Definition

The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)

ShortThe formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
310. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.IntendedUsePart
Definition

The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)

ShortThe intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
312. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.TargetPopulationPart
Definition

The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)

ShortThe target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
314. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.ContainerOrPackPart
Definition

The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)

ShortThe container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
316. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.DevicePart
Definition

The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)

ShortThe device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
318. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.TrademarkOrCompanyNamePart
Definition

The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)

ShortThe trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
320. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Time-PeriodPart
Definition

The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)

ShortThe time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
322. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FlavourPart
Definition

The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)

ShortThe flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
324. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.DelimiterPart
Definition

A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)

ShortA delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
326. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language
Definition

9.2.2.9

Short9.2.2.9
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
328. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
330. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Country
Definition

The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)

ShortThe country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)
Control1..1
TypeCodeableConcept
332. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Jurisdiction
Definition

The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)

ShortThe jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)
Control0..1
TypeCodeableConcept
334. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Language
Definition

The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)

ShortThe language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)
Control1..1
TypeCodeableConcept
336. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct
Definition

11.2.7

Short11.2.7
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
338. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
340. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.IPCID
Definition

This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)

ShortThis is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)
Control1..1
TypeIdentifier
342. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageDescription
Definition

A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)

ShortA textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
344. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier
Definition

9.6.2.8

Short9.6.2.8
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
346. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
348. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.BAID1
Definition

The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)

ShortThe BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)
Control1..1
TypeIdentifier
350. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.BAID2
Definition

The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)

ShortThe BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)
Control0..1
TypeIdentifier
352. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.ExpirationDate
Definition

This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)

ShortThis is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
354. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
356. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
358. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
360. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
362. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
364. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
366. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
368. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
370. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
372. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
374. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
376. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
378. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
380. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
382. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
384. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
386. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
388. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
390. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
392. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
394. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
396. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
398. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
400. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
402. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
404. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
406. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
408. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
410. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
412. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
414. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
416. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
418. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
420. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
422. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
424. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
426. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
428. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
430. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
432. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
434. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
436. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
438. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
440. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
442. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
444. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
446. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container
Definition

9.6.2.3

Short9.6.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
448. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
450. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerType
Definition

The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)

ShortThe package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)
Control1..1
TypeCodeableConcept
452. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerQuantity
Definition

The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)

ShortThe quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)
Control1..1
TypeQuantity
454. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Material
Definition

The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)

ShortThe material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)
Control1..*
TypeCodeableConcept
456. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.AlternateMaterial
Definition

The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)

ShortThe alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)
Control0..*
TypeCodeableConcept
458. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier
Definition

9.6.2.4

Short9.6.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
460. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
462. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.CodeSystem
Definition

The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)

ShortThe data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)
Control1..1
TypeCodeableConcept
464. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.Value
Definition

The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)

ShortThe individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)
Control1..1
TypeCodeableConcept
466. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device
Definition

9.6.2.12

Short9.6.2.12
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
468. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
470. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceType
Definition

The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)

ShortThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
Control1..1
TypeCodeableConcept
472. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceTradeName
Definition

This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)

ShortThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
474. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceQuantity
Definition

The quantity of the device present in the pack shall be specified. (9.6.2.12.4)

ShortThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
Control1..1
TypeQuantity
476. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceListingNumber
Definition

This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)

ShortThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
478. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceIdentifier
Definition

A unique device identifier needs to be specified. (9.6.2.12.6)

ShortA unique device identifier needs to be specified. (9.6.2.12.6)
Control0..1
TypeIdentifier
480. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ModelNumber
Definition

This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)

ShortThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
482. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.SterilityIndicator
Definition

Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)

ShortWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
Control0..1
TypeCodeableConcept
484. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.SterilisationRequirementIndicator
Definition

Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)

ShortWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
Control0..1
TypeCodeableConcept
486. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceUsage
Definition

The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)

ShortThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
Control0..1
TypeCodeableConcept
488. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier
Definition

11.12

Short11.12
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
490. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
492. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.BatchNumber
Definition

Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)

ShortWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
494. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.ExpirationDate
Definition

Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)

ShortWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
496. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial
Definition

9.6.2.13

Short9.6.2.13
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
498. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
500. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Substance
Definition

The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)

ShortThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
Control1..1
TypeCodeableConcept
502. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Alternate
Definition

This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)

ShortThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
Control0..1
TypeElement(BL)
504. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.AllergenicIndicator
Definition

This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)

ShortThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
Control0..1
TypeElement(BL)
506. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature
Definition

11.11

Short11.11
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
508. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
510. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.CodeSystem
Definition

The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)

ShortThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
Control1..1
TypeCodeableConcept
512. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.Value
Definition

The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)

ShortThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
Control1..1
TypeCodeableConcept
514. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
516. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
518. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
520. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
522. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
524. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
526. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
528. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
530. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
532. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
534. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
536. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
538. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
540. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
542. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
544. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
546. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
548. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
550. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
552. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
554. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
556. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
558. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
560. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
562. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
564. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
566. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
568. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
570. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
572. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
574. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
576. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
578. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
580. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
582. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
584. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
586. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
588. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
590. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
592. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
594. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
596. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
598. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
600. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
602. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
604. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
606. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
608. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
610. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeCodeableConcept
612. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeCodeableConcept
614. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics
Definition

11.13

Short11.13
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
616. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
618. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeQuantity
620. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeQuantity
622. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeQuantity
624. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeQuantity
626. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeQuantity
628. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeQuantity
630. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
632. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
634. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
636. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
638. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeCodeableConcept
640. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
642. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
644. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeCodeableConcept
646. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeQuantity
648. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeCodeableConcept
650. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem
Definition

9.6.2.20

Short9.6.2.20
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
652. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
654. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedDoseForm
Definition

This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)

ShortThis describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)
Control1..1
TypeCodeableConcept
656. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.UnitOfPresentation
Definition

This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)

ShortThis specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)
Control0..1
TypeCodeableConcept
658. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedItemQuantity
Definition

The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)

ShortThe quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)
Control1..1
TypeQuantity
660. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient
Definition

11.2.9

Short11.2.9
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
662. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
664. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.IngredientRole
Definition

The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)

ShortThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
Control1..1
TypeCodeableConcept
666. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.AllergenicIndicator
Definition

This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)

ShortThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
Control0..1
TypeElement(BL)
668. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
670. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
672. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
674. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
676. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
678. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
680. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
682. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
684. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
686. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
688. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
690. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
692. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
694. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
696. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
698. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
700. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
702. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
704. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
706. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
708. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
710. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
712. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
714. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
716. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
718. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
720. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
722. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
724. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
726. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
728. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
730. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
732. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
734. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
736. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
738. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
740. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
742. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
744. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
746. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
748. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
750. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
752. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
754. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
756. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
758. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
760. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance
Definition

9.7.2.4

Short9.7.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
762. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
764. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance
Definition

When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)

ShortWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
Control1..1
TypeCodeableConcept
766. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup
Definition

The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)

ShortThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
Control1..1
TypeCodeableConcept
768. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator
Definition

The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)

ShortThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
Control0..1
TypeCodeableConcept
770. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
772. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
774. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeRatio
776. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeRatio
778. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
780. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeCodeableConcept
782. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
784. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
786. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeCodeableConcept
788. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeCodeableConcept
790. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeRatio
792. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
794. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeCodeableConcept
796. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance
Definition

9.7.2.3

Short9.7.2.3
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
798. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
800. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Substance
Definition

A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)

ShortA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
Control1..1
TypeCodeableConcept
802. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
804. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
806. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeRatio
808. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeRatio
810. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
812. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeCodeableConcept
814. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
816. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
818. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeCodeableConcept
820. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeCodeableConcept
822. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeRatio
824. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
826. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeCodeableConcept
828. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
830. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
832. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
834. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
836. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
838. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
840. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
842. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
844. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
846. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
848. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
850. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
852. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
854. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
856. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
858. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
860. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
862. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
864. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
866. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
868. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
870. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
872. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
874. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
876. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
878. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
880. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
882. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
884. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
886. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
888. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
890. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
892. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
894. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
896. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
898. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
900. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
902. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
904. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
906. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
908. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
910. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
912. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
914. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
916. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
918. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
920. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
922. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
924. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeCodeableConcept
926. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeCodeableConcept
928. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics
Definition

11.13

Short11.13
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
930. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
932. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeQuantity
934. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeQuantity
936. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeQuantity
938. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeQuantity
940. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeQuantity
942. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeQuantity
944. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
946. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
948. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
950. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
952. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeCodeableConcept
954. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
956. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
958. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
960. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
962. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
964. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
966. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
968. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
970. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
972. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
974. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
976. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
978. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
980. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
982. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
984. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
986. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
988. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
990. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
992. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
994. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
996. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
998. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
1000. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
1002. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1004. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
1006. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1008. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1010. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1012. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1014. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1016. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1018. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1020. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1022. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1024. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1026. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1028. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1030. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1032. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1034. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1036. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1038. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1040. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1042. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1044. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1046. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1048. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1050. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeCodeableConcept
1052. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeCodeableConcept
1054. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component
Definition

9.6.2.9

Short9.6.2.9
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1056. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1058. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentType
Definition

The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)

ShortThe type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)
Control1..1
TypeCodeableConcept
1060. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentMaterial
Definition

The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)

ShortThe material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)
Control0..*
TypeCodeableConcept
1062. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentAlternateMaterial
Definition

Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)

ShortAlternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)
Control0..*
TypeCodeableConcept
1064. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1066. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1068. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1070. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1072. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1074. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1076. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1078. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1080. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1082. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1084. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1086. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1088. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1090. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1092. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1094. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1096. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1098. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1100. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1102. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1104. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1106. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1108. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
1110. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
1112. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1114. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
1116. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1118. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1120. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1122. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1124. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1126. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1128. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1130. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1132. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1134. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1136. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1138. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1140. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1142. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1144. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1146. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1148. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1150. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1152. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1154. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1156. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics
Definition

11.13

Short11.13
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1158. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1160. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeQuantity
1162. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeQuantity
1164. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeQuantity
1166. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeQuantity
1168. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeQuantity
1170. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeQuantity
1172. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1174. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1176. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1178. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1180. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeCodeableConcept
1182. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics
Definition

11.13

Short11.13
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1184. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1186. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeQuantity
1188. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeQuantity
1190. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeQuantity
1192. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeQuantity
1194. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeQuantity
1196. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeQuantity
1198. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1200. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1202. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1204. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1206. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeCodeableConcept
1208. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1210. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1212. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeCodeableConcept
1214. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeQuantity
1216. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeCodeableConcept
1218. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1220. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1222. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1224. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1226. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1228. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1230. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1232. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1234. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1236. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1238. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1240. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1242. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1244. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1246. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1248. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1250. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1252. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1254. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1256. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1258. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1260. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1262. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
1264. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
1266. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1268. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
1270. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1272. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1274. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1276. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1278. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1280. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1282. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1284. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1286. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1288. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1290. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1292. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1294. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1296. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1298. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1300. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1302. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1304. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1306. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1308. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1310. InvestigationalMedicinalProduct.OrphanDesignation
Definition

9.2.2.3

Short9.2.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1312. InvestigationalMedicinalProduct.OrphanDesignation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1314. InvestigationalMedicinalProduct.OrphanDesignation.OrphanIndicationType
Definition

This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)

ShortThis attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)
Control1..1
TypeCodeableConcept
1316. InvestigationalMedicinalProduct.OrphanDesignation.OrphanProcedureNumber
Definition

This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)

ShortThis attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)
Control0..1
TypeIdentifier
1318. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus
Definition

This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)

ShortThis attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)
Control1..1
TypeCodeableConcept
1320. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate
Definition

This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)

ShortThis attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1322. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationNumber
Definition

This field is to indicate the orphan designation decision number. (9.2.2.3.6)

ShortThis field is to indicate the orphan designation decision number. (9.2.2.3.6)
Control0..1
TypeIdentifier
1324. InvestigationalMedicinalProduct.PharmaceuticalProduct
Definition

11.7.2

Short11.7.2
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1326. InvestigationalMedicinalProduct.PharmaceuticalProduct.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1328. InvestigationalMedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm
Definition

This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)

ShortThis shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)
Control1..1
TypeCodeableConcept
1330. InvestigationalMedicinalProduct.PharmaceuticalProduct.UnitOfPresentation
Definition

The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)

ShortThe unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)
Control0..1
TypeCodeableConcept
1332. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device
Definition

9.6.2.12

Short9.6.2.12
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1334. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1336. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceType
Definition

The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)

ShortThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
Control1..1
TypeCodeableConcept
1338. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName
Definition

This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)

ShortThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1340. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity
Definition

The quantity of the device present in the pack shall be specified. (9.6.2.12.4)

ShortThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
Control1..1
TypeQuantity
1342. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber
Definition

This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)

ShortThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1344. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier
Definition

A unique device identifier needs to be specified. (9.6.2.12.6)

ShortA unique device identifier needs to be specified. (9.6.2.12.6)
Control0..1
TypeIdentifier
1346. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ModelNumber
Definition

This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)

ShortThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1348. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator
Definition

Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)

ShortWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
Control0..1
TypeCodeableConcept
1350. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator
Definition

Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)

ShortWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
Control0..1
TypeCodeableConcept
1352. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage
Definition

The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)

ShortThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
Control0..1
TypeCodeableConcept
1354. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier
Definition

11.12

Short11.12
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1356. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1358. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber
Definition

Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)

ShortWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1360. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate
Definition

Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)

ShortWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1362. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial
Definition

9.6.2.13

Short9.6.2.13
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1364. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1366. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance
Definition

The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)

ShortThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
Control1..1
TypeCodeableConcept
1368. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate
Definition

This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)

ShortThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
Control0..1
TypeElement(BL)
1370. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator
Definition

This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)

ShortThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
Control0..1
TypeElement(BL)
1372. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature
Definition

11.11

Short11.11
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1374. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1376. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem
Definition

The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)

ShortThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
Control1..1
TypeCodeableConcept
1378. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value
Definition

The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)

ShortThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
Control1..1
TypeCodeableConcept
1380. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1382. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1384. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1386. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1388. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1390. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1392. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1394. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1396. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1398. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1400. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1402. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1404. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1406. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1408. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1410. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1412. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1414. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1416. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1418. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1420. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1422. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1424. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
1426. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
1428. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1430. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
1432. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1434. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1436. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1438. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1440. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1442. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1444. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1446. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1448. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1450. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1452. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1454. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1456. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1458. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1460. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1462. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1464. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1466. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1468. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1470. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1472. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1474. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1476. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeCodeableConcept
1478. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeCodeableConcept
1480. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics
Definition

11.13

Short11.13
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1482. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1484. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeQuantity
1486. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeQuantity
1488. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeQuantity
1490. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeQuantity
1492. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeQuantity
1494. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeQuantity
1496. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1498. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1500. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1502. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1504. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeCodeableConcept
1506. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1508. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1510. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeCodeableConcept
1512. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeQuantity
1514. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeCodeableConcept
1516. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration
Definition

11.7.3

Short11.7.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1518. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1520. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.RouteOfAdministration
Definition

(11.7.3.0)

Short (11.7.3.0)
Control1..1
TypeCodeableConcept
1522. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.FirstDoseInHumans
Definition

The first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2)

ShortThe first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2)
Control0..1
TypeQuantity
1524. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumSingleDose
Definition

The maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3)

ShortThe maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3)
Control0..1
TypeQuantity
1526. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumDosePerDay
Definition

The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4)

ShortThe maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4)
Control0..1
TypeQuantity
1528. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumDosePerTreatmentPeriod
Definition

The maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5)

ShortThe maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5)
Control0..1
TypeRatio
1530. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumTreatmentPeriod
Definition

The maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6)

ShortThe maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6)
Control0..1
TypeQuantity
1532. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient
Definition

11.2.9

Short11.2.9
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1534. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1536. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole
Definition

The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)

ShortThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
Control1..1
TypeCodeableConcept
1538. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator
Definition

This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)

ShortThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
Control0..1
TypeElement(BL)
1540. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1542. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1544. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1546. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1548. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1550. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1552. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1554. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1556. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1558. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1560. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1562. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1564. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1566. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1568. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1570. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1572. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1574. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1576. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1578. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1580. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1582. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1584. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
1586. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
1588. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1590. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
1592. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1594. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1596. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1598. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1600. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1602. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1604. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1606. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1608. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1610. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1612. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1614. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1616. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1618. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1620. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1622. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1624. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1626. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1628. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1630. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1632. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance
Definition

9.7.2.4

Short9.7.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1634. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1636. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance
Definition

When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)

ShortWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
Control1..1
TypeCodeableConcept
1638. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup
Definition

The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)

ShortThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
Control1..1
TypeCodeableConcept
1640. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator
Definition

The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)

ShortThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
Control0..1
TypeCodeableConcept
1642. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1644. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1646. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeRatio
1648. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeRatio
1650. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1652. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeCodeableConcept
1654. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1656. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1658. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeCodeableConcept
1660. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeCodeableConcept
1662. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeRatio
1664. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1666. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeCodeableConcept
1668. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance
Definition

9.7.2.3

Short9.7.2.3
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1670. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1672. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance
Definition

A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)

ShortA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
Control1..1
TypeCodeableConcept
1674. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1676. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1678. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeRatio
1680. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeRatio
1682. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1684. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeCodeableConcept
1686. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1688. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1690. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeCodeableConcept
1692. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeCodeableConcept
1694. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeRatio
1696. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1698. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeCodeableConcept
1700. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics
Definition

9.8.2.4

Short9.8.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1702. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1704. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem
Definition

The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)

ShortThe code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)
Control1..1
TypeCodeableConcept
1706. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value
Definition

The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)

ShortThe individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)
Control1..1
TypeCodeableConcept
1708. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status
Definition

The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)

ShortThe status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)
Control0..1
TypeCodeableConcept
1710. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet
Definition

9.8.2.6

Short9.8.2.6
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1712. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1714. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets
Definition

This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)

ShortThis class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)
Control1..1
TypeIdentifier
1716. InvestigationalMedicinalProduct.ProductClassification
Definition

11.3.2.7

Short11.3.2.7
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1718. InvestigationalMedicinalProduct.ProductClassification.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1720. InvestigationalMedicinalProduct.ProductClassification.CodeSystem
Definition

The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)

ShortThe Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)
Control1..1
TypeCodeableConcept
1722. InvestigationalMedicinalProduct.ProductClassification.Value
Definition

The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)

ShortThe individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)
Control1..1
TypeCodeableConcept
1724. InvestigationalMedicinalProduct.ProductCross-Reference
Definition

11.3.2.4

Short11.3.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1726. InvestigationalMedicinalProduct.ProductCross-Reference.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1728. InvestigationalMedicinalProduct.ProductCross-Reference.I-MPIDCross-Reference
Definition

This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)

ShortThis is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)
Control1..1
TypeIdentifier
1730. InvestigationalMedicinalProduct.ProductCross-Reference.ReferencedProductType
Definition

This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)

ShortThis attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)
Control0..1
TypeCodeableConcept
1732. InvestigationalMedicinalProduct.TherapeuticIndication
Definition

9.9.2.2

Short9.9.2.2
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1734. InvestigationalMedicinalProduct.TherapeuticIndication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1736. InvestigationalMedicinalProduct.TherapeuticIndication.IndicationText
Definition

The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)

ShortThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1738. InvestigationalMedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)

ShortThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
Control0..1
TypeCodeableConcept
1740. InvestigationalMedicinalProduct.TherapeuticIndication.DiseaseStatus
Definition

The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)

ShortThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
Control0..1
TypeCodeableConcept
1742. InvestigationalMedicinalProduct.TherapeuticIndication.Comorbidity
Definition

If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)

ShortIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
Control0..*
TypeCodeableConcept
1744. InvestigationalMedicinalProduct.TherapeuticIndication.IntendedEffect
Definition

The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)

ShortThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
Control0..1
TypeCodeableConcept
1746. InvestigationalMedicinalProduct.TherapeuticIndication.Timing-Duration
Definition

If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)

ShortIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
Control0..1
TypeQuantity
1748. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1750. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1752. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeCodeableConcept
1754. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeCodeableConcept
1756. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1758. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1760. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
1762. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
1764. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
1766. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
1768. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
1770. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept
1772. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1774. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1776. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1778. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeCodeableConcept
1780. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeCodeableConcept
1782. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeCodeableConcept
1784. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1786. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1788. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
1790. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
1792. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
1794. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
1796. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
1798. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept
1800. InvestigationalMedicinalProduct.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1802. InvestigationalMedicinalProduct.UndesirableEffects.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1804. InvestigationalMedicinalProduct.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1806. InvestigationalMedicinalProduct.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeCodeableConcept
1808. InvestigationalMedicinalProduct.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeCodeableConcept
1810. InvestigationalMedicinalProduct.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeCodeableConcept
1812. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1814. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1816. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
1818. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
1820. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
1822. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
1824. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
1826. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept

Guidance on how to interpret the contents of this table can be found here

0. InvestigationalMedicinalProduct
Definition

ISO 11615 Investigational Medicinal Product

Control0..*
Is Modifierfalse
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. InvestigationalMedicinalProduct.IMPID
Definition

The identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2)

ShortThe identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2)
Control1..1
TypeIdentifier
4. InvestigationalMedicinalProduct.CombinedPharmaceuticalDoseForm
Definition

The combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3)

ShortThe combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3)
Control0..1
TypeCodeableConcept
6. InvestigationalMedicinalProduct.SponsorProductCode
Definition

The product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4)

ShortThe product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
8. InvestigationalMedicinalProduct.RegulatorProductCode
Definition

The product code (identifier) for the Investigational Medicinal Product as designated by the Medicines Regulatory Agency can be specified in text. Either this code or the sponsor product code (see 11.3. 2.2.4 ) shall be specified. (11.3.2.2.5)

ShortThe product code (identifier) for the Investigational Medicinal Product as designated by the Medicines Regulatory Agency can be specified in text. Either this code or the sponsor product code (see 11.3. 2.2.4 ) shall be specified. (11.3.2.2.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
10. InvestigationalMedicinalProduct.PaediatricUseIndicator
Definition

If the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6)

ShortIf the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6)
Control0..1
TypeCodeableConcept
12. InvestigationalMedicinalProduct.ClinicalTrialStatus
Definition

The status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7)

ShortThe status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7)
Control0..1
TypeCodeableConcept
14. InvestigationalMedicinalProduct.OrphanDesignationStatus
Definition

See 9.2.2.2.7 . (11.3.2.2.8)

ShortSee 9.2.2.2.7 . (11.3.2.2.8)
Control0..1
TypeCodeableConcept
16. InvestigationalMedicinalProduct.AttachedDocument
Definition

11.3.2.6

Short11.3.2.6
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. InvestigationalMedicinalProduct.AttachedDocument.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
20. InvestigationalMedicinalProduct.AttachedDocument.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.AttachedDocument.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
22. InvestigationalMedicinalProduct.AttachedDocument.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
24. InvestigationalMedicinalProduct.AttachedDocument.Identifier
Definition

The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)

ShortThe reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)
Control1..1
TypeIdentifier
26. InvestigationalMedicinalProduct.AttachedDocument.EffectiveDate
Definition

The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)

ShortThe date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
28. InvestigationalMedicinalProduct.AttachedDocument.Type
Definition

The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)

ShortThe type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)
Control1..1
TypeCodeableConcept
30. InvestigationalMedicinalProduct.AttachedDocument.Content
Definition

The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)

ShortThe actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)
Control1..1
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
32. InvestigationalMedicinalProduct.AttachedDocument.Language
Definition

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)

ShortThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)
Control0..1
TypeCodeableConcept
34. InvestigationalMedicinalProduct.AttachedDocument.MediaType
Definition

This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)

ShortThis attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)
Control0..1
TypeCodeableConcept
36. InvestigationalMedicinalProduct.AttachedDocument.VersionNumber
Definition

This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)

ShortThis is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
38. InvestigationalMedicinalProduct.AttachedDocument.VersionSetIdentifier
Definition

This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)

ShortThis is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)
Control0..1
TypeIdentifier
40. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation
Definition

11.4.2.2

Short11.4.2.2
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
44. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
46. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
48. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.RegistrationNumber
Definition

The registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2)

ShortThe registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2)
Control1..1
TypeIdentifier
50. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.InvestigationCode
Definition

The code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3)

ShortThe code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
52. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Country
Definition

The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4)

ShortThe jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4)
Control1..*
TypeCodeableConcept
54. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.ProtocolNumber
Definition

The number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5)

ShortThe number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5)
Control1..1
TypeIdentifier
56. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.AuthorisationDate
Definition

The date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6)

ShortThe date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
58. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.AnticipatedEndDate
Definition

The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7)

ShortThe date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
60. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation
Definition

11.4.2.3

Short11.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
64. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
66. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
68. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalClinicalTrialRegistrationNumber
Definition

The registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2)

ShortThe registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2)
Control1..1
TypeIdentifier
70. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalInvestigationCode
Definition

The “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3)

ShortThe “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
72. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.Jurisdiction
Definition

The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4)

ShortThe jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4)
Control1..*
TypeCodeableConcept
74. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalAuthorisationDate
Definition

The date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5)

ShortThe date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
76. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalAnticipatedEndDate
Definition

The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6)

ShortThe date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
78. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control1..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
82. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
84. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
86. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
88. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
90. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
92. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
94. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
96. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
98. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
100. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
102. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
104. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
106. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
108. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
110. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
112. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
114. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
116. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
118. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
120. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
122. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
124. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
126. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
128. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
130. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation
Definition

11.4.2.4

Short11.4.2.4
Control1..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
132. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
134. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
136. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
138. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
140. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
142. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
144. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
146. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
148. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
150. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
152. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
154. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
156. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
158. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
160. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
162. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
164. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
166. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
168. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
170. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
172. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
174. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
176. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
178. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
180. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
182. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME
Definition

9.3.2.4

Short9.3.2.4
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
184. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
186. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor_Organisation.SME.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
188. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
190. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.SMEFlag
Definition

This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)

ShortThis is a flag to indicate if the organisation is an SME. (9.3.2.4.1)
Control1..1
TypeElement(BL)
192. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.Size
Definition

The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)

ShortThe size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)
Control0..1
TypeCodeableConcept
194. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.SMENumber
Definition

This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)

ShortThis is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)
Control0..1
TypeIdentifier
196. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.StatusDate
Definition

This is the date when the SME status was granted. (9.3.2.4.4)

ShortThis is the date when the SME status was granted. (9.3.2.4.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
198. InvestigationalMedicinalProduct.Contraindication
Definition

9.9.2.3

Short9.9.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
200. InvestigationalMedicinalProduct.Contraindication.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
202. InvestigationalMedicinalProduct.Contraindication.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
204. InvestigationalMedicinalProduct.Contraindication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
206. InvestigationalMedicinalProduct.Contraindication.ContraindicationsText
Definition

The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)

ShortThe text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
208. InvestigationalMedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)

ShortThe underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)
Control0..1
TypeCodeableConcept
210. InvestigationalMedicinalProduct.Contraindication.DiseaseStatus
Definition

The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)

ShortThe status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)
Control0..1
TypeCodeableConcept
212. InvestigationalMedicinalProduct.Contraindication.Comorbidity
Definition

The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)

ShortThe comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)
Control0..*
TypeCodeableConcept
214. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
216. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
218. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
220. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
222. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeCodeableConcept
224. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeCodeableConcept
226. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
228. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
230. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
232. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
234. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
236. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
238. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
240. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
242. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
244. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept
246. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication
Definition

9.9.2.2

Short9.9.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
248. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
250. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
252. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
254. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IndicationText
Definition

The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)

ShortThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
256. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)

ShortThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
Control0..1
TypeCodeableConcept
258. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus
Definition

The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)

ShortThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
Control0..1
TypeCodeableConcept
260. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity
Definition

If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)

ShortIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
Control0..*
TypeCodeableConcept
262. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect
Definition

The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)

ShortThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
Control0..1
TypeCodeableConcept
264. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration
Definition

If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)

ShortIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
Control0..1
TypeQuantity
266. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
268. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
270. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
272. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
274. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeCodeableConcept
276. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeCodeableConcept
278. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
280. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
282. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
284. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
286. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
288. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
290. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
292. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
294. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
296. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept
298. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
300. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
302. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
304. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
306. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
308. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeCodeableConcept
310. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeCodeableConcept
312. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeCodeableConcept
314. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
316. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
318. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
320. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
322. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
324. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
326. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
328. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
330. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
332. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept
334. InvestigationalMedicinalProduct.Header
Definition

11.3.2.5

Short11.3.2.5
Control1..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
336. InvestigationalMedicinalProduct.Header.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
338. InvestigationalMedicinalProduct.Header.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Header.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
340. InvestigationalMedicinalProduct.Header.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
342. InvestigationalMedicinalProduct.Header.Identifier
Definition

This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)

ShortThis attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)
Control1..1
TypeIdentifier
344. InvestigationalMedicinalProduct.Header.EffectiveDate
Definition

The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)

ShortThe date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
346. InvestigationalMedicinalProduct.Header.Language
Definition

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)

ShortThis attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)
Control0..1
TypeCodeableConcept
348. InvestigationalMedicinalProduct.Header.VersionNumber
Definition

This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)

ShortThis is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
350. InvestigationalMedicinalProduct.Header.VersionSetIdentifier
Definition

This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)

ShortThis is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)
Control0..1
TypeIdentifier
352. InvestigationalMedicinalProduct.Interactions
Definition

9.9.2.7

Short9.9.2.7
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
354. InvestigationalMedicinalProduct.Interactions.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
356. InvestigationalMedicinalProduct.Interactions.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Interactions.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
358. InvestigationalMedicinalProduct.Interactions.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
360. InvestigationalMedicinalProduct.Interactions.InteractionsText
Definition

The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)

ShortThe text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
362. InvestigationalMedicinalProduct.Interactions.Interactant
Definition

This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)

ShortThis element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)
Control0..*
TypeCodeableConcept
364. InvestigationalMedicinalProduct.Interactions.InteractionsType
Definition

The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)

ShortThe type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)
Control0..1
TypeCodeableConcept
366. InvestigationalMedicinalProduct.Interactions.InteractionsEffect
Definition

The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)

ShortThe effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)
Control0..1
TypeCodeableConcept
368. InvestigationalMedicinalProduct.Interactions.InteractionsIncidence
Definition

The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)

ShortThe incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)
Control0..1
TypeCodeableConcept
370. InvestigationalMedicinalProduct.Interactions.ManagementActions
Definition

The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)

ShortThe actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)
Control0..1
TypeCodeableConcept
372. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName
Definition

11.3.2.8

Short11.3.2.8
Control1..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
374. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
376. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
378. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
380. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FullName
Definition

The full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1)

ShortThe full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
382. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Code
Definition

The Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2)

ShortThe Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
384. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.InventedNamePart
Definition

The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)

ShortThe invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
386. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.ScientificNamePart
Definition

The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)

ShortThe scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
388. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.StrengthPart
Definition

The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)

ShortThe strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
390. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.PharmaceuticalDoseFormPart
Definition

The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)

ShortThe pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
392. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FormulationPart
Definition

The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)

ShortThe formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
394. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.IntendedUsePart
Definition

The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)

ShortThe intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
396. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.TargetPopulationPart
Definition

The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)

ShortThe target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
398. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.ContainerOrPackPart
Definition

The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)

ShortThe container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
400. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.DevicePart
Definition

The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)

ShortThe device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
402. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.TrademarkOrCompanyNamePart
Definition

The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)

ShortThe trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
404. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Time-PeriodPart
Definition

The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)

ShortThe time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
406. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FlavourPart
Definition

The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)

ShortThe flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
408. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.DelimiterPart
Definition

A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)

ShortA delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
410. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language
Definition

9.2.2.9

Short9.2.2.9
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
412. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
414. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
416. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
418. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Country
Definition

The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)

ShortThe country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)
Control1..1
TypeCodeableConcept
420. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Jurisdiction
Definition

The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)

ShortThe jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)
Control0..1
TypeCodeableConcept
422. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Language
Definition

The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)

ShortThe language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)
Control1..1
TypeCodeableConcept
424. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct
Definition

11.2.7

Short11.2.7
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
426. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
428. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
430. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
432. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.IPCID
Definition

This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)

ShortThis is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)
Control1..1
TypeIdentifier
434. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageDescription
Definition

A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)

ShortA textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
436. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier
Definition

9.6.2.8

Short9.6.2.8
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
438. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
440. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
442. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
444. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.BAID1
Definition

The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)

ShortThe BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)
Control1..1
TypeIdentifier
446. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.BAID2
Definition

The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)

ShortThe BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)
Control0..1
TypeIdentifier
448. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.ExpirationDate
Definition

This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)

ShortThis is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
450. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
452. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
454. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
456. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
458. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
460. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
462. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
464. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
466. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
468. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
470. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
472. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
474. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
476. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
478. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
480. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
482. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
484. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
486. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
488. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
490. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
492. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
494. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
496. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
498. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
500. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
502. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
504. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
506. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
508. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
510. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
512. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
514. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
516. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
518. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
520. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
522. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
524. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
526. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
528. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
530. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
532. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
534. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
536. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
538. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
540. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
542. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
544. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
546. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
548. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
550. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
552. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
554. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
556. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
558. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
560. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
562. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
564. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
566. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
568. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
570. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container
Definition

9.6.2.3

Short9.6.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
572. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
574. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
576. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
578. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerType
Definition

The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)

ShortThe package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)
Control1..1
TypeCodeableConcept
580. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerQuantity
Definition

The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)

ShortThe quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)
Control1..1
TypeQuantity
582. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Material
Definition

The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)

ShortThe material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)
Control1..*
TypeCodeableConcept
584. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.AlternateMaterial
Definition

The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)

ShortThe alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)
Control0..*
TypeCodeableConcept
586. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier
Definition

9.6.2.4

Short9.6.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
588. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
590. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
592. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
594. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.CodeSystem
Definition

The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)

ShortThe data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)
Control1..1
TypeCodeableConcept
596. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.Value
Definition

The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)

ShortThe individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)
Control1..1
TypeCodeableConcept
598. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device
Definition

9.6.2.12

Short9.6.2.12
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
600. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
602. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
604. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
606. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceType
Definition

The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)

ShortThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
Control1..1
TypeCodeableConcept
608. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceTradeName
Definition

This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)

ShortThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
610. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceQuantity
Definition

The quantity of the device present in the pack shall be specified. (9.6.2.12.4)

ShortThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
Control1..1
TypeQuantity
612. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceListingNumber
Definition

This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)

ShortThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
614. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceIdentifier
Definition

A unique device identifier needs to be specified. (9.6.2.12.6)

ShortA unique device identifier needs to be specified. (9.6.2.12.6)
Control0..1
TypeIdentifier
616. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ModelNumber
Definition

This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)

ShortThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
618. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.SterilityIndicator
Definition

Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)

ShortWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
Control0..1
TypeCodeableConcept
620. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.SterilisationRequirementIndicator
Definition

Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)

ShortWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
Control0..1
TypeCodeableConcept
622. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceUsage
Definition

The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)

ShortThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
Control0..1
TypeCodeableConcept
624. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier
Definition

11.12

Short11.12
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
626. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
628. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
630. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
632. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.BatchNumber
Definition

Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)

ShortWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
634. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.ExpirationDate
Definition

Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)

ShortWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
636. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial
Definition

9.6.2.13

Short9.6.2.13
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
638. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
640. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
642. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
644. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Substance
Definition

The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)

ShortThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
Control1..1
TypeCodeableConcept
646. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Alternate
Definition

This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)

ShortThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
Control0..1
TypeElement(BL)
648. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.AllergenicIndicator
Definition

This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)

ShortThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
Control0..1
TypeElement(BL)
650. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature
Definition

11.11

Short11.11
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
652. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
654. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
656. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
658. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.CodeSystem
Definition

The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)

ShortThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
Control1..1
TypeCodeableConcept
660. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.Value
Definition

The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)

ShortThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
Control1..1
TypeCodeableConcept
662. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
664. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
666. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
668. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
670. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
672. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
674. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
676. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
678. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
680. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
682. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
684. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
686. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
688. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
690. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
692. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
694. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
696. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
698. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
700. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
702. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
704. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
706. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
708. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
710. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
712. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
714. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
716. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
718. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
720. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
722. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
724. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
726. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
728. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
730. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
732. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
734. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
736. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
738. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
740. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
742. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
744. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
746. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
748. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
750. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
752. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
754. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
756. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
758. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
760. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
762. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
764. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
766. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
768. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
770. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
772. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
774. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
776. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
778. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
780. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
782. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
784. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
786. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
788. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
790. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeCodeableConcept
792. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeCodeableConcept
794. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics
Definition

11.13

Short11.13
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
796. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
798. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
800. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
802. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeQuantity
804. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeQuantity
806. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeQuantity
808. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeQuantity
810. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeQuantity
812. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeQuantity
814. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
816. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
818. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
820. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
822. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeCodeableConcept
824. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
826. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
828. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
830. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
832. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeCodeableConcept
834. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeQuantity
836. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeCodeableConcept
838. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem
Definition

9.6.2.20

Short9.6.2.20
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
840. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
842. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
844. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
846. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedDoseForm
Definition

This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)

ShortThis describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)
Control1..1
TypeCodeableConcept
848. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.UnitOfPresentation
Definition

This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)

ShortThis specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)
Control0..1
TypeCodeableConcept
850. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedItemQuantity
Definition

The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)

ShortThe quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)
Control1..1
TypeQuantity
852. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient
Definition

11.2.9

Short11.2.9
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
854. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
856. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
858. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
860. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.IngredientRole
Definition

The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)

ShortThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
Control1..1
TypeCodeableConcept
862. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.AllergenicIndicator
Definition

This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)

ShortThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
Control0..1
TypeElement(BL)
864. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
866. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
868. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
870. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
872. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
874. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
876. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
878. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
880. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
882. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
884. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
886. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
888. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
890. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
892. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
894. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
896. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
898. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
900. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
902. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
904. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
906. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
908. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
910. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
912. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
914. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
916. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
918. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
920. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
922. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
924. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
926. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
928. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
930. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
932. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
934. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
936. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
938. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
940. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
942. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
944. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
946. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
948. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
950. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
952. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
954. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
956. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
958. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
960. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
962. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
964. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
966. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
968. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
970. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
972. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
974. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
976. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
978. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
980. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
982. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
984. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance
Definition

9.7.2.4

Short9.7.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
986. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
988. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
990. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
992. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance
Definition

When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)

ShortWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
Control1..1
TypeCodeableConcept
994. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup
Definition

The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)

ShortThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
Control1..1
TypeCodeableConcept
996. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator
Definition

The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)

ShortThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
Control0..1
TypeCodeableConcept
998. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1000. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1002. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1004. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1006. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeRatio
1008. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeRatio
1010. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1012. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeCodeableConcept
1014. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1016. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1018. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1020. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1022. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeCodeableConcept
1024. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeCodeableConcept
1026. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeRatio
1028. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1030. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeCodeableConcept
1032. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance
Definition

9.7.2.3

Short9.7.2.3
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1034. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1036. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1038. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1040. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Substance
Definition

A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)

ShortA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
Control1..1
TypeCodeableConcept
1042. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1044. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1046. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1048. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1050. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeRatio
1052. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeRatio
1054. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1056. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeCodeableConcept
1058. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1060. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1062. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1064. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1066. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeCodeableConcept
1068. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeCodeableConcept
1070. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeRatio
1072. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1074. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeCodeableConcept
1076. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1078. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1080. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1082. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1084. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1086. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1088. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1090. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1092. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1094. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1096. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1098. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1100. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1102. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1104. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1106. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1108. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1110. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1112. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1114. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1116. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1118. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1120. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1122. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1124. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1126. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1128. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1130. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1132. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1134. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1136. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
1138. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
1140. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1142. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
1144. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1146. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1148. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1150. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1152. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1154. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1156. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1158. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1160. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1162. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1164. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1166. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1168. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1170. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1172. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1174. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1176. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1178. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1180. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1182. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1184. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1186. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1188. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1190. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1192. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1194. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1196. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1198. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1200. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1202. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1204. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeCodeableConcept
1206. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeCodeableConcept
1208. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics
Definition

11.13

Short11.13
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1210. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1212. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1214. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1216. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeQuantity
1218. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeQuantity
1220. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeQuantity
1222. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeQuantity
1224. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeQuantity
1226. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeQuantity
1228. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1230. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1232. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1234. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1236. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeCodeableConcept
1238. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1240. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1242. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1244. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1246. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1248. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1250. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1252. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1254. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1256. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1258. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1260. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1262. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1264. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1266. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1268. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1270. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1272. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1274. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1276. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1278. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1280. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1282. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1284. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1286. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1288. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1290. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1292. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1294. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1296. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1298. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
1300. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
1302. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1304. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
1306. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1308. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1310. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1312. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1314. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1316. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1318. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1320. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1322. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1324. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1326. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1328. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1330. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1332. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1334. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1336. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1338. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1340. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1342. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1344. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1346. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1348. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1350. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1352. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1354. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1356. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1358. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1360. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1362. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1364. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1366. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeCodeableConcept
1368. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeCodeableConcept
1370. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component
Definition

9.6.2.9

Short9.6.2.9
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1372. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1374. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1376. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1378. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentType
Definition

The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)

ShortThe type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)
Control1..1
TypeCodeableConcept
1380. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentMaterial
Definition

The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)

ShortThe material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)
Control0..*
TypeCodeableConcept
1382. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentAlternateMaterial
Definition

Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)

ShortAlternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)
Control0..*
TypeCodeableConcept
1384. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1386. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1388. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1390. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1392. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1394. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1396. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1398. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1400. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1402. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1404. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1406. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1408. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1410. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1412. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1414. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1416. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1418. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1420. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1422. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1424. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1426. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1428. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1430. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1432. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1434. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1436. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1438. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1440. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1442. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1444. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
1446. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
1448. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1450. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
1452. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1454. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1456. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1458. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1460. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1462. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1464. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1466. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1468. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1470. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1472. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1474. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1476. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1478. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1480. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1482. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1484. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1486. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1488. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1490. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1492. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1494. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1496. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1498. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1500. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1502. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1504. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics
Definition

11.13

Short11.13
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1506. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1508. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1510. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1512. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeQuantity
1514. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeQuantity
1516. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeQuantity
1518. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeQuantity
1520. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeQuantity
1522. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeQuantity
1524. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1526. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1528. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1530. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1532. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeCodeableConcept
1534. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics
Definition

11.13

Short11.13
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1536. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1538. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1540. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1542. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeQuantity
1544. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeQuantity
1546. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeQuantity
1548. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeQuantity
1550. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeQuantity
1552. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeQuantity
1554. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1556. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1558. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1560. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1562. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeCodeableConcept
1564. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1566. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1568. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1570. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1572. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeCodeableConcept
1574. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeQuantity
1576. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeCodeableConcept
1578. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1580. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1582. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1584. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1586. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1588. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1590. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1592. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1594. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1596. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1598. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1600. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1602. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1604. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1606. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1608. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1610. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1612. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1614. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1616. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1618. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1620. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1622. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1624. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1626. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1628. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1630. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1632. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1634. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1636. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1638. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
1640. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
1642. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1644. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
1646. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1648. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1650. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1652. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1654. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1656. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1658. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1660. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1662. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1664. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1666. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1668. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1670. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1672. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1674. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1676. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1678. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1680. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1682. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1684. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1686. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1688. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1690. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1692. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1694. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1696. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1698. InvestigationalMedicinalProduct.OrphanDesignation
Definition

9.2.2.3

Short9.2.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1700. InvestigationalMedicinalProduct.OrphanDesignation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1702. InvestigationalMedicinalProduct.OrphanDesignation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.OrphanDesignation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1704. InvestigationalMedicinalProduct.OrphanDesignation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1706. InvestigationalMedicinalProduct.OrphanDesignation.OrphanIndicationType
Definition

This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)

ShortThis attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)
Control1..1
TypeCodeableConcept
1708. InvestigationalMedicinalProduct.OrphanDesignation.OrphanProcedureNumber
Definition

This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)

ShortThis attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)
Control0..1
TypeIdentifier
1710. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus
Definition

This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)

ShortThis attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)
Control1..1
TypeCodeableConcept
1712. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate
Definition

This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)

ShortThis attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1714. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationNumber
Definition

This field is to indicate the orphan designation decision number. (9.2.2.3.6)

ShortThis field is to indicate the orphan designation decision number. (9.2.2.3.6)
Control0..1
TypeIdentifier
1716. InvestigationalMedicinalProduct.PharmaceuticalProduct
Definition

11.7.2

Short11.7.2
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1718. InvestigationalMedicinalProduct.PharmaceuticalProduct.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1720. InvestigationalMedicinalProduct.PharmaceuticalProduct.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1722. InvestigationalMedicinalProduct.PharmaceuticalProduct.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1724. InvestigationalMedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm
Definition

This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)

ShortThis shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)
Control1..1
TypeCodeableConcept
1726. InvestigationalMedicinalProduct.PharmaceuticalProduct.UnitOfPresentation
Definition

The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)

ShortThe unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)
Control0..1
TypeCodeableConcept
1728. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device
Definition

9.6.2.12

Short9.6.2.12
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1730. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1732. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1734. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1736. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceType
Definition

The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)

ShortThe type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)
Control1..1
TypeCodeableConcept
1738. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName
Definition

This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)

ShortThis can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1740. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity
Definition

The quantity of the device present in the pack shall be specified. (9.6.2.12.4)

ShortThe quantity of the device present in the pack shall be specified. (9.6.2.12.4)
Control1..1
TypeQuantity
1742. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber
Definition

This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)

ShortThis can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1744. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier
Definition

A unique device identifier needs to be specified. (9.6.2.12.6)

ShortA unique device identifier needs to be specified. (9.6.2.12.6)
Control0..1
TypeIdentifier
1746. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ModelNumber
Definition

This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)

ShortThis can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1748. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator
Definition

Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)

ShortWhere applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)
Control0..1
TypeCodeableConcept
1750. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator
Definition

Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)

ShortWhere applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)
Control0..1
TypeCodeableConcept
1752. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage
Definition

The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)

ShortThe number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)
Control0..1
TypeCodeableConcept
1754. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier
Definition

11.12

Short11.12
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1756. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1758. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1760. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1762. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber
Definition

Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)

ShortWhere applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1764. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate
Definition

Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)

ShortWhere applicable, the expiration date for the batch can be specified. (9.6.2.15.3)
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1766. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial
Definition

9.6.2.13

Short9.6.2.13
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1768. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1770. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1772. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1774. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance
Definition

The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)

ShortThe substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)
Control1..1
TypeCodeableConcept
1776. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate
Definition

This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)

ShortThis flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)
Control0..1
TypeElement(BL)
1778. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator
Definition

This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)

ShortThis flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)
Control0..1
TypeElement(BL)
1780. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature
Definition

11.11

Short11.11
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1782. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1784. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1786. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1788. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem
Definition

The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)

ShortThe device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)
Control1..1
TypeCodeableConcept
1790. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value
Definition

The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)

ShortThe term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)
Control1..1
TypeCodeableConcept
1792. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1794. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1796. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1798. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1800. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1802. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1804. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1806. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1808. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1810. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1812. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1814. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1816. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1818. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1820. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1822. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1824. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1826. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1828. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1830. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1832. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1834. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1836. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1838. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1840. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1842. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1844. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1846. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1848. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1850. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1852. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
1854. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
1856. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1858. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
1860. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1862. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1864. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1866. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1868. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
1870. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1872. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
1874. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
1876. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1878. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1880. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1882. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1884. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1886. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
1888. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
1890. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
1892. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
1894. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1896. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1898. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1900. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1902. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1904. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
1906. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
1908. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
1910. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1912. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics
Definition

9.6.2.22

Short9.6.2.22
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1914. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1916. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1918. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1920. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem
Definition

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

ShortThe code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)
Control1..1
TypeCodeableConcept
1922. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value
Definition

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

ShortThe individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)
Control1..1
TypeCodeableConcept
1924. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics
Definition

11.13

Short11.13
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1926. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1928. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1930. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1932. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height
Definition

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

ShortWhere applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)
Control0..1
TypeQuantity
1934. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width
Definition

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

ShortWhere applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)
Control0..1
TypeQuantity
1936. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth
Definition

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

ShortWhere applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)
Control0..1
TypeQuantity
1938. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight
Definition

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

ShortWhere applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)
Control0..1
TypeQuantity
1940. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume
Definition

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

ShortWhere applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)
Control0..1
TypeQuantity
1942. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter
Definition

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

ShortWhere applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)
Control0..1
TypeQuantity
1944. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape
Definition

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

ShortWhere applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1946. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour
Definition

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

ShortWhere applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1948. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint
Definition

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

ShortWhere applicable, the imprint can be specified as text. (9.6.2.21.10)
Control0..*
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1950. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image
Definition

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

ShortWhere applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)
Control0..*
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
1952. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring
Definition

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

ShortWhere applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)
Control0..1
TypeCodeableConcept
1954. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage
Definition

9.6.2.11

Short9.6.2.11
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1956. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1958. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1960. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1962. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType
Definition

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)
Control1..1
TypeCodeableConcept
1964. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod
Definition

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)
Control1..1
TypeQuantity
1966. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage
Definition

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)
Control0..*
TypeCodeableConcept
1968. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration
Definition

11.7.3

Short11.7.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1970. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1972. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1974. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1976. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.RouteOfAdministration
Definition

(11.7.3.0)

Short (11.7.3.0)
Control1..1
TypeCodeableConcept
1978. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.FirstDoseInHumans
Definition

The first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2)

ShortThe first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2)
Control0..1
TypeQuantity
1980. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumSingleDose
Definition

The maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3)

ShortThe maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3)
Control0..1
TypeQuantity
1982. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumDosePerDay
Definition

The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4)

ShortThe maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4)
Control0..1
TypeQuantity
1984. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumDosePerTreatmentPeriod
Definition

The maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5)

ShortThe maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5)
Control0..1
TypeRatio
1986. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumTreatmentPeriod
Definition

The maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6)

ShortThe maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6)
Control0..1
TypeQuantity
1988. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient
Definition

11.2.9

Short11.2.9
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
1990. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
1992. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
1994. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
1996. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole
Definition

The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)

ShortThe role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)
Control1..1
TypeCodeableConcept
1998. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator
Definition

This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)

ShortThis flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)
Control0..1
TypeElement(BL)
2000. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation
Definition

9.5.2.2

Short9.5.2.2
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2002. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2004. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2006. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2008. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
2010. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2012. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
2014. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
2016. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2018. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2020. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2022. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2024. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2026. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
2028. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
2030. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
2032. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
2034. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2036. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2038. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2040. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2042. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2044. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
2046. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
2048. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
2050. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2052. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation
Definition

9.5.2.3

Short9.5.2.3
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2054. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2056. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2058. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2060. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType
Definition

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

ShortThe type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)
Control1..1
TypeCodeableConcept
2062. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber
Definition

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

ShortThe reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)
Control0..1
TypeIdentifier
2064. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate
Definition

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

ShortThe effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)
Control0..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2066. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator
Definition

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

ShortThe level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)
Control0..1
TypeCodeableConcept
2068. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation
Definition

9.3.2.5

Short9.3.2.5
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2070. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2072. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2074. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2076. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier
Definition

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

ShortThe unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)
Control1..1
TypeIdentifier
2078. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name
Definition

The name of the organisation shall be provided in text. (9.4.2.2.3)

ShortThe name of the organisation shall be provided in text. (9.4.2.2.3)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2080. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address
Definition

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

ShortThe address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)
Control1..1
TypeAddress
2082. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator
Definition

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

ShortThe confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)
Control0..1
TypeCodeableConcept
2084. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2086. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact
Definition

9.4.2.4

Short9.4.2.4
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2088. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2090. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2092. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2094. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name
Definition

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

ShortThe name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)
Control0..1
TypeHumanName
2096. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom
Definition

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

ShortThe telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)
Control1..*
TypeContactPoint
2098. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role
Definition

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

ShortThe role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)
Control1..1
TypeCodeableConcept
2100. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator
Definition

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

ShortThe confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)
Control0..1
TypeCodeableConcept
2102. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations
Definition

9.4.2.3

Short9.4.2.3
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2104. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2106. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2108. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2110. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName
Definition

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

ShortThis is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2112. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress
Definition

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

ShortThe address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)
Control1..1
TypeAddress
2114. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole
Definition

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

ShortThe role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)
Control1..1
TypeCodeableConcept
2116. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier
Definition

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

ShortThe unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)
Control0..1
TypeIdentifier
2118. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates
Definition

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

ShortThese are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2120. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance
Definition

9.7.2.4

Short9.7.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2122. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2124. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2126. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2128. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance
Definition

When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)

ShortWhen a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)
Control1..1
TypeCodeableConcept
2130. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup
Definition

The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)

ShortThe group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)
Control1..1
TypeCodeableConcept
2132. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator
Definition

The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)

ShortThe confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)
Control0..1
TypeCodeableConcept
2134. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2136. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2138. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2140. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2142. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeRatio
2144. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeRatio
2146. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2148. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeCodeableConcept
2150. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2152. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2154. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2156. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2158. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeCodeableConcept
2160. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeCodeableConcept
2162. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeRatio
2164. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2166. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeCodeableConcept
2168. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance
Definition

9.7.2.3

Short9.7.2.3
Control0..1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2170. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2172. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2174. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2176. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance
Definition

A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)

ShortA substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)
Control1..1
TypeCodeableConcept
2178. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength
Definition

9.7.2.5

Short9.7.2.5
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2180. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2182. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2184. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2186. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Presentation
Definition

The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)

ShortThe strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)
Control1..1
TypeRatio
2188. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Concentration
Definition

The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)

ShortThe strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)
Control0..1
TypeRatio
2190. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint
Definition

There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)

ShortThere are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2192. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country
Definition

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)

ShortThe country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)
Control0..*
TypeCodeableConcept
2194. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength
Definition

9.7.2.6

Short9.7.2.6
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2196. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2198. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2200. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2202. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance
Definition

If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)

ShortIf a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)
Control0..1
TypeCodeableConcept
2204. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance
Definition

If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)

ShortIf a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)
Control0..1
TypeCodeableConcept
2206. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength
Definition

The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)

ShortThe reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)
Control1..1
TypeRatio
2208. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint
Definition

The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)

ShortThe reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2210. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry
Definition

Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)

ShortWhere a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)
Control0..*
TypeCodeableConcept
2212. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics
Definition

9.8.2.4

Short9.8.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2214. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2216. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2218. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2220. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem
Definition

The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)

ShortThe code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)
Control1..1
TypeCodeableConcept
2222. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value
Definition

The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)

ShortThe individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)
Control1..1
TypeCodeableConcept
2224. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status
Definition

The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)

ShortThe status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)
Control0..1
TypeCodeableConcept
2226. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet
Definition

9.8.2.6

Short9.8.2.6
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2228. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2230. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2232. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2234. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets
Definition

This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)

ShortThis class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)
Control1..1
TypeIdentifier
2236. InvestigationalMedicinalProduct.ProductClassification
Definition

11.3.2.7

Short11.3.2.7
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2238. InvestigationalMedicinalProduct.ProductClassification.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2240. InvestigationalMedicinalProduct.ProductClassification.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.ProductClassification.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2242. InvestigationalMedicinalProduct.ProductClassification.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2244. InvestigationalMedicinalProduct.ProductClassification.CodeSystem
Definition

The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)

ShortThe Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)
Control1..1
TypeCodeableConcept
2246. InvestigationalMedicinalProduct.ProductClassification.Value
Definition

The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)

ShortThe individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)
Control1..1
TypeCodeableConcept
2248. InvestigationalMedicinalProduct.ProductCross-Reference
Definition

11.3.2.4

Short11.3.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2250. InvestigationalMedicinalProduct.ProductCross-Reference.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2252. InvestigationalMedicinalProduct.ProductCross-Reference.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.ProductCross-Reference.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2254. InvestigationalMedicinalProduct.ProductCross-Reference.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2256. InvestigationalMedicinalProduct.ProductCross-Reference.I-MPIDCross-Reference
Definition

This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)

ShortThis is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)
Control1..1
TypeIdentifier
2258. InvestigationalMedicinalProduct.ProductCross-Reference.ReferencedProductType
Definition

This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)

ShortThis attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)
Control0..1
TypeCodeableConcept
2260. InvestigationalMedicinalProduct.TherapeuticIndication
Definition

9.9.2.2

Short9.9.2.2
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2262. InvestigationalMedicinalProduct.TherapeuticIndication.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2264. InvestigationalMedicinalProduct.TherapeuticIndication.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.TherapeuticIndication.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2266. InvestigationalMedicinalProduct.TherapeuticIndication.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2268. InvestigationalMedicinalProduct.TherapeuticIndication.IndicationText
Definition

The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)

ShortThe authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2270. InvestigationalMedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure
Definition

The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)

ShortThe underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)
Control0..1
TypeCodeableConcept
2272. InvestigationalMedicinalProduct.TherapeuticIndication.DiseaseStatus
Definition

The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)

ShortThe status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)
Control0..1
TypeCodeableConcept
2274. InvestigationalMedicinalProduct.TherapeuticIndication.Comorbidity
Definition

If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)

ShortIf there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)
Control0..*
TypeCodeableConcept
2276. InvestigationalMedicinalProduct.TherapeuticIndication.IntendedEffect
Definition

The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)

ShortThe intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)
Control0..1
TypeCodeableConcept
2278. InvestigationalMedicinalProduct.TherapeuticIndication.Timing-Duration
Definition

If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)

ShortIf there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)
Control0..1
TypeQuantity
2280. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics
Definition

9.9.2.6

Short9.9.2.6
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2282. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2284. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2286. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2288. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType
Definition

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

ShortThe type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)
Control1..1
TypeCodeableConcept
2290. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.Medication
Definition

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

ShortReference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)
Control1..1
TypeCodeableConcept
2292. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control1..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2294. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2296. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2298. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2300. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
2302. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
2304. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
2306. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
2308. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
2310. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept
2312. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2314. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2316. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2318. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2320. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2322. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeCodeableConcept
2324. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeCodeableConcept
2326. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeCodeableConcept
2328. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2330. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2332. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2334. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2336. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
2338. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
2340. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
2342. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
2344. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
2346. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept
2348. InvestigationalMedicinalProduct.UndesirableEffects
Definition

9.9.2.4

Short9.9.2.4
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2350. InvestigationalMedicinalProduct.UndesirableEffects.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2352. InvestigationalMedicinalProduct.UndesirableEffects.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.UndesirableEffects.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2354. InvestigationalMedicinalProduct.UndesirableEffects.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2356. InvestigationalMedicinalProduct.UndesirableEffects.UndesirableEffectText
Definition

The text of the undesirable effect shall be given. (9.9.2.4.2)

ShortThe text of the undesirable effect shall be given. (9.9.2.4.2)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
2358. InvestigationalMedicinalProduct.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect
Definition

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

ShortThe symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)
Control0..1
TypeCodeableConcept
2360. InvestigationalMedicinalProduct.UndesirableEffects.Symptom-Condition-EffectClassification
Definition

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

ShortThe classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)
Control0..1
TypeCodeableConcept
2362. InvestigationalMedicinalProduct.UndesirableEffects.FrequencyOfOccurrence
Definition

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

ShortThe frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)
Control0..1
TypeCodeableConcept
2364. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics
Definition

9.9.2.5

Short9.9.2.5
Control0..*
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2366. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
2368. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
2370. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2372. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Age
Definition

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

ShortThe age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)
Control0..1
TypeCodeableConcept
2374. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeLow
Definition

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

ShortThe lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)
Control0..1
TypeQuantity
2376. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeHigh
Definition

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

ShortThe upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)
Control0..1
TypeQuantity
2378. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Gender
Definition

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

ShortThe gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)
Control0..1
TypeCodeableConcept
2380. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Race
Definition

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

ShortThe race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)
Control0..1
TypeCodeableConcept
2382. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition
Definition

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

ShortVarious aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)
Control0..1
TypeCodeableConcept